Device typeUltrasound-guided gastrostomy system catheter: A sterile, flexible, tubular device with an inflatable balloon and a magnet at its distal end intended to be placed in the stomach, via the oesophagus, and used to move the stomach to the anterior abdominal wall via attraction by an external magnet (not included), to facilitate a gastrostomy. The balloon is filled with a fluid (e.g., saline) to enable detection by an ultrasound imaging system (not included) for its optimal placement without intervention of other anatomical structures (e.g., organs, vessels). Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire) may be included. This is a single-use device.
FDA categoryTube, Gastro-Enterostomy
Device ID00850026037203
Catalog number0010381
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information